Ers2 - Ergoline Rehabilitation System

Transmitters And Receivers, Physiological Signal, Radiofrequency

Ergoline GmbH

The following data is part of a premarket notification filed by Ergoline Gmbh with the FDA for Ers2 - Ergoline Rehabilitation System.

Pre-market Notification Details

Device IDK212883
510k NumberK212883
Device Name:Ers2 - Ergoline Rehabilitation System
ClassificationTransmitters And Receivers, Physiological Signal, Radiofrequency
Applicant ergoline GmbH Lindenstrasse 5 Bitz,  DE 72475
ContactAlexandra Lertz
CorrespondentAlexandra Lertz
ergoline GmbH Lindenstrasse 5 Bitz,  DE 72475
Product CodeDRG  
CFR Regulation Number870.2910 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-09-10
Decision Date2022-07-15

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